On 16 April 2018, HRA Approval became HRA and Health and Care Research Wales (HCRW) Approval and now applies to all project-based research taking place in the NHS in England and Wales. We are in the process of updating our online guidance to reflect this. For information on how to prepare and submit an application for HRA and HCRW Approval please refer to the IRAS website. For information relating to site setup and local processes for the NHS in Wales please refer to the HCRW website.
When considering which organisations will act as potential study sites, sponsors are strongly advised to have preliminary discussions with potential participating NHS organisations before submitting the IRAS form in order to understand if those organisations have the potential to participate.
It is at this stage that potential participating organisations can assess their capacity and capability to participate in the study. To start this discussion, the minimum information that you should send to the potential participating NHS organisation is the version of the protocol that will be submitted for HRA Approval.
Some sponsors may require a formal assessment phase and may undertake a site selection visit to determine if the organisation will be invited to participate in the study.
Organisations that have agreed that they might be able to participate in the study should be identified on 'part C' of the IRAS form. If additional participating organisations are identified after initial submission then these can be added by the appropriate notification of amendment after HRA Approval.
The process for setting up NHS sites in England will differ slightly depending on the lead nation. The lead nation for a study is based on the location of the study’s lead NHS Research and Development (R&D) office.
Setting up NHS sites in England in studies where the lead site is in EnglandOnce the sponsor receives the HRA Approval initial assessment letter (or HRA Approval letter in cases where no initial assessment letter is issued) they can contact participating NHS sites in England to provide them with the 'local information pack' and finalise discussions around confirming capacity and capability.
Once all the arrangements have been put in place to deliver a study, the participating NHS organisation will provide you with confirmation of this via email, indicating that they are ready to start the study. The actual date at which you wish to start research activities at the site should have already been agreed and may be dependent on a site initiation visit or similar that you wish to conduct.
You can find contact details for R&D staff and your relevant local Clinical Research Network (CRN) by visiting the NHS R&D forum website.
The local information pack should contain;
· Copy of IRAS Form as submitted Protocol and amendments
· Participant information and consent documents (without local logos/ headers)
· Relevant model agreement
· Localised Organisational Information Delegation log (where applicable, including known research team names but not signatures, or indicate when this will be shared)
· Commercial studies only – NIHR Costing template (validated)
· Non-commercial studies only - Schedule of Event or Schedule of Event Cost Attribution Tool
· Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study
· Copy of Initial assessment letter (if one is issued) and (when issued) HRA Approval letter and final documents.The HRA initial assessment or HRA Approval letter will provide information relevant to study set up. Any cost negotiations that are required with the participating organisation can be finalised at this stage.
In addition, if researchers who are not employed by the participating organisation will deliver research activities locally, you should work with the research management function for the site to put HR arrangements in place in accordance with the HR Good Practice Resource Pack (Research Passport guidance)
The HRA provides a free eLearning module explaining the HRA Schedule of events.
Collaborative working where no formal confirmation of capacity and capability is expected
This document provides information supplementary to the Initial Assessment Letter and/or the Letter of HRA Approval for sponsors and NHS organisations undertaking a study where there are participating NHS organisations in England that are not expected to formally confirm capacity and capability:
- Collaborative working between sponsors and NHS organisations in England for HRA Approval studies, where no formal confirmation of capacity and capability is expected.
Assessing, Arranging, and Confirming: clarifications on HRA terminology
This document provides clarity about some of the activities that the HRA expects to be undertaken at the local level to support research delivery in the NHS in England for HRA Approval studies.
Setting up NHS sites in England in studies where the lead site is in Scotland, Wales or Northern IrelandThe lead nation will undertake the UK study wide review (in England this is incorporated into the HRA assessment) and share the application and the outcome of the UK study wide review with the other participating nations. . If there are sites in England the lead nation will share the application and outcome with the HRA.
Sponsors are advised to contact the HRA at the earliest opportunity so that the HRA Approval team can facilitate the review of the research study for English sites. If the lead nation is outside England, and there are NHS sites in England, HRA will accept the study-wide review and complete nation-specific elements before issuing HRA Approval.
Once HRA Approval has been received sponsors can provide sites with the local information pack and finalise capacity and capability arrangements as above.
The HRA will provide additional support to applicants for studies where the lead NHS R&D office is in Northern Ireland, Scotland and Wales and the study has sites in England. If you require support please contact email@example.com making clear that your study is led from Scotland, Wales or Northern Ireland.
Study set up in primary care settings
This document outlines seven key principles to be followed when setting-up and delivering a study in primary care, as well as some examples to demonstrate the principles involved:
Participating NHS Organisations in Scotland, Wales or Northern Ireland
Sponsors are expected to have discussed the project with local researchers at the participating organisations and the relevant R&D office. For participating organisations in Northern Ireland, Scotland and Wales we would recommend that you visit the content that is available on IRAS.
Participating non-NHS Organisations
If your study includes non-NHS research sites and is a CTIMP or Clinical Investigation of a Medical Device, then the non-NHS/HSC Site Assessment Form should be completed in IRAS and should be provided as part of the application documents.
Participant Identification Centres (PICs)
If you are looking for information about PICs, please read the guidance available in IRAS.